Long-term Clinical Follow-up Analysis of Patients With Lumbar Disease.

Recruiting now

Conditions studied: Lumbar Disease

In brief

This study is a long-term follow-up of postoperative clinical outcomes in patients with lumbar spine disorders, monitoring spine implants SmartMIS Spinal Fixation System and ASA Spinal Fixation System. Patients will be selected based on inclusion and exclusion criteria. The informed consent process will be initiated by the physician. A questionnaire-based survey will be conducted, which includes the Visual Analog Scale (VAS), Oswestry Disability Index (ODI), and Fusion Rate. Subjects will complete the same questionnaire assessments preoperatively and at 6 ± 3 months, 12 ± 3 months, and 24 ± 3 months postoperatively. The total number of subjects to be enrolled is 120. The total duration of the study is expected to be 4 years.

Key facts

Study ID

NCT06933004

Run by

National Taiwan University Hospital

People needed

120

Starts

2025-05-01

Expected to finish

2028-03-31

Last updated by the study team

2025-04-17

Who can join

Age: 20 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged between 20 and 80 years.
• Patients with lumbar spine disorders requiring surgical treatment.
• Able to understand the study content after explanation, capable of expressing their experiences, and willing to sign the written informed consent form.

You may not qualify if…

• Individuals with impaired decision-making capacity or from vulnerable populations.
• Individuals who are unable or unwilling to return for follow-up assessments.

Where it is running

• National Taiwan University Hospital — Taipei, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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